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Belimumab has been studied in an active lupus nephritis, phase 3 trial call BLISS-LN and shown to be effective as measured by trial of belimumab for the treatment of active lupus nephritis in adult patients.
This 2 year randomized, double-blind, placebo-controlled trial compared the efficacy and safety of belimumab 10mg/kg intravenous (IV) versus placebo in patients receiving backgrou standard therapy (mycophenolate mofetil for induction and maintenance, or cyclophosphamide for induction followed by azathioprine for maintenance, plus steroids)
A total of 448 adult patients with lupus nephritis were treated and the primary endpoints was renal response (PERR), defined as eGFR ≥60mL/min/1.73m2 or no decrease in eGFR from pre-flare of >20%; and urinary protein: creatinine ratio (uPCR) ≤0.7; and not a treatment failure.
The results showed belimumab to be superior to placebo with significantly more patients achieving a renal response over over 2 years (43% vs 32%; P =.0311).
With regard to safety, adverse events were observed to be similar between the belimumab and placebo groups and consistent with the safety profile for belimumab.
Belimumab also superior to placebo for secondary endpoints: Complete Renal Response (CRR), and time to death or renal-related event.
Benlysta is currently not recommended, nor approved for use in severe active lupus nephritis.
The full results will be submitted for future presentation at upcoming scientific meetings and in peer-reviewed publications.